SANISUDS FOAM HAND SANITIZER- benzalkonium chloride soap 
Palmer Fixture Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

Warnings

For external use only.
When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Case Label - 3 x 1200 mL Bags

SANISUDS FOAM HAND SANITIZER 
benzalkonium chloride soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:48417-750
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1.00 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
Product Characteristics
Color white (water white - colorless, dispensed as a white foam) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48417-750-02 3 in 1 BOX
1 1200 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 04/07/2009
Labeler - Palmer Fixture Company (185454241)

Revised: 3/2014
Document Id: fe5d7193-3d51-4b9c-b34c-79f0c0238911
Set id: 00d0e5b0-09aa-417f-9dc3-5dea59e57340
Version: 3
Effective Time: 20140307
 
Palmer Fixture Company